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NCT04257825 Clinical Trial

Use of Temperature Controlling Mattress Pad for Sleep Improvement

Sleep Clinical Trial

Official title:
The Chili + OURA Sleep Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04257825
Other study ID # 2206
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 31, 2019
Est. completion date February 28, 2020

Study information
Verified date February 2020
Source ProofPilot
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A dual arm interventional study in which chliipad and ooler sleep system users voluntarily opt out of using their device for 2 out of 4 weeks. Assessments of sleep via self report and Oura Ring sleep quality and duration.

Recruitment information / eligibility
Status Recruiting
Enrollment 133
Est. completion date February 28, 2020
Est. primary completion date February 28, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria:

- has a chili sleep system

- has an Oura Ring

Exclusion Criteria:

- medically treatable issue

- recent injury

- expected significant travel over study period

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Chili Sleep System
A mattress pad that cools or warms bed to maintain a constant temperature.

Locations
Country Name City State
United States ProofPilot (Virtual Study: https://p.proofpilot.com) New York New York

Sponsors (2)
Lead Sponsor Collaborator
ProofPilot Kryo Inc

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Deep Sleep as Measured by Oura Ring Oura Ring is a connected health device worn on the finger that measures sleep. Deep sleep summaries per day will be compared between week 1 and week 2. From week 1 to week 2
Primary Change in self-reported sleep quality via Jenkins Sleep Scale A 8 item self-assessment questionnaire of sleep quality. From week 1 to week 2
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